Alirocumab for the treatment of hyperlipidemia in high-risk patients: an updated review.

Alirocumab is a fully human immunoglobulin G1 monoclonal antibody directed against proprotein convertase subtilisin/kexin type 9 (PCSK9) approved for the treatment of hypercholesterolemia in high-risk patients. The objective is to provide an updated review of the recent data published for alirocumab. Areas covered: The efficacy and safety of alirocumab has been initially evaluated in a comprehensive phase 3 program conducted in more than 6 000 patients with primary non-familial and heterozygous familial hypercholesterolemia: alirocumab reduced LDL-cholesterol up to 62% in phase 3 with every 2-week dosing compared with placebo, and up to 36% compared with ezetimibe, with an excellent safety and tolerability profile. Herein, the author describes new efficacy and safety data obtained from complementary analyses of the phase 3 program submitted for approval and reports data from new specific trials. Expert commentary: Based on current high pricing, the patient groups prioritized for alirocumab treatment are patients with heterozygous familial hypercholesterolemia and patients with atherosclerotic cardiovascular disease who have substantially elevated LDL cholesterol on maximally tolerated statin plus ezetimibe therapy. The ongoing ODYSSEY OUTCOMES trial will provide important information on the cost-effectiveness of alirocumab treatment.